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Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005 (PDF/199.01 KB)

Last updated: 24/03/2021
Active substance: Tramadol
Procedure number: PSUSA/00003002/202005
Regulatory outcome: Variation
Bulgarian
(PDF/228.07 KB)

Croatian
(PDF/247.66 KB)

Czech
(PDF/282.64 KB)

Danish
(PDF/178.93 KB)

Dutch
(PDF/189.31 KB)

Estonian
(PDF/196.26 KB)

Finnish
(PDF/195.52 KB)

French
(PDF/105.6 KB)

German
(PDF/203.88 KB)

Greek
(PDF/255.31 KB)

Greek
(PDF/255.31 KB)

Hungarian
(PDF/269.79 KB)

Icelandic
(PDF/213.74 KB)

Italian
(PDF/220.66 KB)

Latvian
(PDF/246.72 KB)

Lithuanian
(PDF/244.77 KB)

Maltese
(PDF/283.18 KB)

Norwegian
(PDF/208.41 KB)

Polish
(PDF/241.34 KB)

Portuguese
(PDF/183.34 KB)

Romanian
(PDF/220.02 KB)

Slovak
(PDF/248.59 KB)

Slovenian
(PDF/241.04 KB)

Spanish
(PDF/214.08 KB)

Swedish
(PDF/171.02 KB)
List item

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Last updated: 13/09/2018
Active substance: spironolactone, hydrochlorothiazide
Procedure number: PSUSA/00001662/201801
Regulatory outcome: Maintenance
List item

Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708 (PDF/32.74 KB)

Last updated: 13/09/2018
Active substance: naproxen
Procedure number: PSUSA/00002125/201708
Regulatory outcome: Variation
Bulgarian
(PDF/112.63 KB)

Croatian
(PDF/100.3 KB)

Czech
(PDF/89.6 KB)

Danish
(PDF/38.79 KB)

Dutch
(PDF/32.68 KB)

Estonian
(PDF/39.52 KB)

Finnish
(PDF/36.98 KB)

French
(PDF/58.73 KB)

German
(PDF/34.02 KB)

Greek
(PDF/94.01 KB)

Hungarian
(PDF/86.24 KB)

Icelandic
(PDF/35.57 KB)

Italian
(PDF/39.9 KB)

Latvian
(PDF/96.1 KB)

Lithuanian
(PDF/90.5 KB)

Maltese
(PDF/119.1 KB)

Norwegian
(PDF/34.49 KB)

Polish
(PDF/97.29 KB)

Portuguese
(PDF/38.87 KB)

Romanian
(PDF/90.29 KB)

Slovak
(PDF/95.88 KB)

Slovenian
(PDF/92.68 KB)

Spanish
(PDF/39.2 KB)

Swedish
(PDF/38.61 KB)
List item

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Last updated: 12/09/2018
Active substance: Lubiprostone
Procedure number: PSUSA/00010290/201801
Regulatory outcome: Maintenance
List item

Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801 (PDF/123.44 KB)

Last updated: 12/09/2018
Active substance: cimicifuga racemosa (L.) nutt., rhizoma
Procedure number: PSUSA/00000755/201801
Regulatory outcome: Maintenance
List item

Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712 (PDF/156.43 KB)

Last updated: 11/09/2018
Active substance: Tobramycin
Procedure number: PSUSA/00009316/201712
Regulatory outcome: Maintenance
List item

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Last updated: 11/09/2018
Active substance: cyproheptadine
Procedure number: PSUSA/00000902/201712
Regulatory outcome: Maintenance
List item

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation
List item

Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712 (PDF/45.82 KB)

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation
Bulgarian
(PDF/194.76 KB)

Croatian
(PDF/76.64 KB)

Czech
(PDF/85.21 KB)

Danish
(PDF/60.1 KB)

Dutch
(PDF/32.46 KB)

Estonian
(PDF/160.5 KB)

Finnish
(PDF/86.04 KB)

French
(PDF/49.91 KB)

German
(PDF/58.14 KB)

Greek
(PDF/96.13 KB)

Hungarian
(PDF/85.51 KB)

Icelandic
(PDF/162.78 KB)

Italian
(PDF/177.21 KB)

Latvian
(PDF/107.22 KB)

Lithuanian
(PDF/155.93 KB)

Maltese
(PDF/90.85 KB)

Norwegian
(PDF/125.64 KB)

Polish
(PDF/171.82 KB)

Portuguese
(PDF/55.85 KB)

Romanian
(PDF/143.38 KB)

Slovak
(PDF/86.64 KB)

Slovenian
(PDF/81.83 KB)

Spanish
(PDF/115.7 KB)

Swedish
(PDF/50.36 KB)
List item

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Last updated: 11/09/2018
Active substance: acebutolol
Procedure number: PSUSA/00000018/201712
Regulatory outcome: Maintenance
List item

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Last updated: 11/09/2018
Active substance: felodipine
Procedure number: PSUSA/00001356/201712
Regulatory outcome: Maintenance
List item

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

Last updated: 10/09/2018
Active substance: Furosemide
Procedure number: PSUSA/00001491/201801
Regulatory outcome: Maintenance
List item

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Last updated: 10/09/2018
Active substance: betahistine
Procedure number: PSUSA/00000389/201712
Regulatory outcome: Maintenance
List item

Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801 (PDF/103.97 KB)

Last updated: 10/09/2018
Active substance: tetanus vaccines
Procedure number: PSUSA/00002910/201801
Regulatory outcome: Maintenance
List item

Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711 (PDF/98.15 KB)

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
Bulgarian
(PDF/305.37 KB)

Croatian
(PDF/183.53 KB)

Czech
(PDF/211.83 KB)

Danish
(PDF/162.47 KB)

Dutch
(PDF/113.85 KB)

Estonian
(PDF/276.16 KB)

Finnish
(PDF/175.1 KB)

French
(PDF/169.48 KB)

German
(PDF/127.86 KB)

Greek
(PDF/356.94 KB)

Hungarian
(PDF/167.68 KB)

Icelandic
(PDF/266.57 KB)

Italian
(PDF/246.26 KB)

Latvian
(PDF/249.66 KB)

Lithuanian
(PDF/281.89 KB)

Maltese
(PDF/330.08 KB)

Norwegian
(PDF/312.69 KB)

Polish
(PDF/340.26 KB)

Portuguese
(PDF/125.86 KB)

Romanian
(PDF/261.2 KB)

Slovak
(PDF/250.45 KB)

Slovenian
(PDF/323.3 KB)

Spanish
(PDF/212.78 KB)

Swedish
(PDF/190.79 KB)
List item

Ibutilide: List of nationally authorised medicinal products - PSUSA/00001713/201712 (PDF/80.23 KB)

Last updated: 10/09/2018
Active substance: ibutilide
Procedure number: PSUSA/00001713/201712
Regulatory outcome: Maintenance
List item

Tapentadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201711 (PDF/52.62 KB)

Last updated: 07/09/2018
Active substance: tapentadol
Procedure number: PSUSA/00002849/201711
Regulatory outcome: Variation
Bulgarian
(PDF/146.74 KB)

Croatian
(PDF/141.58 KB)

Czech
(PDF/443.47 KB)

Danish
(PDF/54.31 KB)

Dutch
(PDF/53.74 KB)

Estonian
(PDF/425.24 KB)

Finnish
(PDF/54.08 KB)

French
(PDF/69.07 KB)

German
(PDF/56.58 KB)

Greek
(PDF/127.77 KB)

Hungarian
(PDF/124.58 KB)

Icelandic
(PDF/53.52 KB)

Italian
(PDF/55.5 KB)

Latvian
(PDF/129.88 KB)

Lithuanian
(PDF/127.91 KB)

Maltese
(PDF/504.58 KB)

Norwegian
(PDF/52.99 KB)

Polish
(PDF/133.05 KB)

Portuguese
(PDF/68.82 KB)

Romanian
(PDF/126.81 KB)

Slovak
(PDF/128.36 KB)

Slovenian
(PDF/430.96 KB)

Spanish
(PDF/53.35 KB)

Swedish
(PDF/74.28 KB)
List item

Mizolastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002078/201711 (PDF/34.31 KB)

Last updated: 05/09/2018
Active substance: mizolastine
Procedure number: PSUSA/00002078/201711
Regulatory outcome: Variation
Bulgarian
(PDF/75.12 KB)

Croatian
(PDF/85.88 KB)

Czech
(PDF/102.28 KB)

Danish
(PDF/37.78 KB)

Dutch
(PDF/31.89 KB)

Estonian
(PDF/29.12 KB)

Finnish
(PDF/33.46 KB)

French
(PDF/36.38 KB)

German
(PDF/36.61 KB)

Greek
(PDF/106.58 KB)

Hungarian
(PDF/92.45 KB)

Icelandic
(PDF/29.15 KB)

Italian
(PDF/39.66 KB)

Latvian
(PDF/100.51 KB)

Lithuanian
(PDF/97.19 KB)

Maltese
(PDF/66.19 KB)

Norwegian
(PDF/31.99 KB)

Polish
(PDF/103.47 KB)

Portuguese
(PDF/57.32 KB)

Romanian
(PDF/83.3 KB)

Slovak
(PDF/94.36 KB)

Slovenian
(PDF/63.65 KB)

Spanish
(PDF/39.48 KB)

Swedish
(PDF/32.81 KB)
List item

Atorvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010347/201710 (PDF/52.49 KB)

Last updated: 24/08/2018
Active substance: Atorvastatin
Procedure number: PSUSA/00010347/201710
Regulatory outcome: Variation
Bulgarian
(PDF/159.88 KB)

Croatian
(PDF/111.08 KB)

Czech
(PDF/150.73 KB)

Danish
(PDF/53.21 KB)

Dutch
(PDF/57.08 KB)

Estonian
(PDF/55.09 KB)

Finnish
(PDF/55.02 KB)

French
(PDF/55.51 KB)

German
(PDF/56.22 KB)

Greek
(PDF/156.96 KB)

Hungarian
(PDF/113.47 KB)

Icelandic
(PDF/50.27 KB)

Italian
(PDF/54.12 KB)

Latvian
(PDF/153.58 KB)

Lithuanian
(PDF/133.54 KB)

Maltese
(PDF/143.63 KB)

Norwegian
(PDF/56.02 KB)

Polish
(PDF/146.92 KB)

Portuguese
(PDF/55.19 KB)

Romanian
(PDF/136.51 KB)

Slovak
(PDF/115.05 KB)

Slovenian
(PDF/129.32 KB)

Spanish
(PDF/55.45 KB)

Swedish
(PDF/53.02 KB)
List item

Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 (PDF/104.04 KB)

Last updated: 16/08/2018
Active substance: benzoyl peroxide, adapalene
Procedure number: PSUSA/00000059/201709
Regulatory outcome: Variation
Bulgarian
(PDF/125.22 KB)

Croatian
(PDF/131.65 KB)

Danish
(PDF/115.01 KB)

Dutch
(PDF/112.88 KB)

Finnish
(PDF/96.79 KB)

French
(PDF/25.55 KB)

German
(PDF/109.39 KB)

Greek
(PDF/108.93 KB)

Hungarian
(PDF/105.09 KB)

Icelandic
(PDF/105.83 KB)

Italian
(PDF/122.22 KB)

Latvian
(PDF/126.62 KB)

Lithuanian
(PDF/103.96 KB)

Maltese
(PDF/104.53 KB)

Norwegian
(PDF/102.08 KB)

Polish
(PDF/105.34 KB)

Portuguese
(PDF/103.29 KB)

Romanian
(PDF/101.45 KB)

Slovak
(PDF/106.19 KB)

Slovenian
(PDF/102.33 KB)

Spanish
(PDF/93.63 KB)

Swedish
(PDF/116.31 KB)
List item

Dutasteride, dutasteride / tamsulosine: List of nationally authorised medicinal products - PSUSA/00010506/201711 (PDF/188.56 KB)

Last updated: 14/08/2018
Active substance: dutasteride, tamsulosin
Procedure number: PSUSA/00010506/201711
Regulatory outcome: Maintenance
List item

Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201711 (PDF/277.02 KB)

Last updated: 14/08/2018
Active substance: glatiramer
Procedure number: PSUSA/00001529/201711
Regulatory outcome: Maintenance
List item

Alfuzosin: List of nationally authorised medicinal products - (PDF/300.84 KB)

Last updated: 14/08/2018
Active substance: alfuzosin
Procedure number: PSUSA/00000084/201711
Regulatory outcome: Maintenance
List item

Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/201710 (PDF/218.35 KB)

Last updated: 14/08/2018
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/201710
Regulatory outcome: Variation
Bulgarian
(PDF/390.85 KB)

Croatian
(PDF/302.5 KB)

Czech
(PDF/391.89 KB)

Danish
(PDF/221.13 KB)

Dutch
(PDF/219.82 KB)

Estonian
(PDF/213.82 KB)

Finnish
(PDF/210.2 KB)

French
(PDF/222.17 KB)

German
(PDF/190.18 KB)

Greek
(PDF/350.53 KB)

Hungarian
(PDF/314.68 KB)

Icelandic
(PDF/220.35 KB)

Italian
(PDF/217.72 KB)

Latvian
(PDF/392.57 KB)

Lithuanian
(PDF/387.24 KB)

Maltese
(PDF/394.42 KB)

Norwegian
(PDF/216.64 KB)

Polish
(PDF/392.85 KB)

Portuguese
(PDF/219.74 KB)

Romanian
(PDF/382.08 KB)

Slovak
(PDF/451.87 KB)

Slovenian
(PDF/388.38 KB)

Spanish
(PDF/248.31 KB)

Swedish
(PDF/218.08 KB)
List item

Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)

Last updated: 13/08/2018
Active substance: Atorvastatin
Procedure number: PSUSA/00010347/201710
Regulatory outcome: Variation

334 results

Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005 (PDF/199.01 KB)

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708 (PDF/32.74 KB)

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801 (PDF/123.44 KB)

Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712 (PDF/156.43 KB)

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712 (PDF/45.82 KB)

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801 (PDF/103.97 KB)

Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711 (PDF/98.15 KB)

Ibutilide: List of nationally authorised medicinal products - PSUSA/00001713/201712 (PDF/80.23 KB)

Tapentadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002849/201711 (PDF/52.62 KB)

Mizolastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002078/201711 (PDF/34.31 KB)

Atorvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010347/201710 (PDF/52.49 KB)

Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 (PDF/104.04 KB)

Dutasteride, dutasteride / tamsulosine: List of nationally authorised medicinal products - PSUSA/00010506/201711 (PDF/188.56 KB)

Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201711 (PDF/277.02 KB)

Alfuzosin: List of nationally authorised medicinal products - (PDF/300.84 KB)

Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/201710 (PDF/218.35 KB)

Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710 (PDF/885.03 KB)